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LEPU Medical SARS-CoV-2 Antigen Rapid Test – Anterio Nasal Test

LEPU Medical SARS-CoV-2 Antigen Rapid Test – Anterio Nasal Test

Innovative Painless Convenient

The LEPU Medical SARS CoV 2 Antigen Rapid Test is a test card that eliminates one processing step, separate sample preparation with the extraction buffer. This leads to a certain reduction of errors in handling and can save time in test procedure and also minimize the potential risk of infection for the user. Therefore, this test is particularly suitable for use in fields where users do not have a professional laboratory routine for performing an IVD diagnostic. This LEPU Medical Antigen Test stands out from all conventional rapid tests due to its intuitive operation with only a few steps.

The LEPU Medical Antigen Test detects pathogen-specific N-proteins (Nucleocapsid-N) and thus also identifies the new virus mutations. This is a mandatory criterion of the Federal Institute for Drugs and Medical Devices (BfArM) since 15.01.2021.

The LEPU Medical Antigen Test is easy to use for swabbing anterio- nasal and easy to evaluate without sample preparation step, therefore the LEPU Medical Antigen Rapid Test saves considerable time in the test procedure.

All necessary materials for the test are included in the LEPU Medical test kit. The test result is already available after 15 minutes.

Product details

◦ LEPU Medical SARS Cov2 Antigen Rapid Test is licensed for anterio-nasal use (test procedure is painless).

◦ No tube test

◦ Enables the evidence of acute SARS-CoV-2 infection

◦ Sensitive as against different mutations

◦ Listed at the Federal Institute for Drugs and Medical Devices (BfArM)

◦ Evaluated by the Paul-Ehrlich-Institute (PEI)

◦ Simple test procedure

◦ Reliable results

◦ Test results after 15 minutes

◦ High test capacity through minimal time investment

◦ Sensitivity: 96,06%

◦ Specificity: 99,62%

◦ No (antibody) cross reaction with usual influenza viruses

◦ Test procedure location-independant and no need of a lab

Contents of the kit

◦ Kit contains 25 SARS-CoV-2 Antigen rapid test Kit cards

◦ 25 sterile swabs

◦ 2x4 ml extraction buffers (can be ordered in single disposable squeezing vials)

◦ instruction for use

Quality management

◦ EN ISO 13485:2016

◦ CoA, stability studies according to EC Directive 98/79/EC

◦ EC- Reg. MP: NL-CA002-2020-53290-GZ: CIBG-20201307

Further product details:

◦ Licensed as anterio-nasal test

◦ EAN number:4260717030004

◦ PZN number: 17212657

Do you have any questions concerning our products or do you want to order SARS-Cov2 tests directly?

Please call us on our info hotline at 06239 9265700 or send an inquiry to [email protected]

Lepu Antigen Test